Sandoz Execs Reflect on a Decade of Experience With the BPCIA, Look to Biosimilars' Future

When the Affordable Care Act was signed into law in March 2010, with its inclusion of the Biologics Price Competition and Innovation Act (BPCIA) that created a pathway for biosimilar approval, it ushered in the era of biosimilars in the United States.

The first developer to see a biosimilar approved via the newly created pathway was Sandoz with its filgrastim biosimilar, Zarxio, which was FDA approved and launched in 2015. That product has been a US success story, particularly as it reached 50% market share for filgrastim just this year. Sandoz is also the most recent company to launch a biosimilar, having made its pegfilgrastim product, Ziextenzo, available in the United States just this month.

In an interview with The Center for Biosimilars^®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the past decade of experience with the biosimilar pathway and gave a look at the future of Sandoz’s biosimilar efforts.

According to Frame, some of the key developments with respect to clarifying the application of the BPCIA have come relatively recently in the form of the FDA’s Biosimilar Action Plan, including its provision to establish a new Office of Therapeutic Biologics and Biosimilars to improve coordination and support of activities under the Biosimilar User Fee Act program and accelerate responses to stakeholders.

But looking to the future, she said, Sandoz continues to have concerns about the BPCIA’s interchangeability provision, a feature of the biosimilar pathway that is present only in the US regulatory landscape.

“It's such a unique factor in the United States compared to the rest of the world that I think it’s our view that it has introduced an unnecessary hurdle and has created a perception, somehow, that there’s an extra level of efficacy and safety that that comes along with the interchangeability hurdle,” said Frame. “It’s our view that it certainly is unnecessary, and certainly doesn’t add any value—it adds additional costs…I’m not sure that we see that there’s really a need for that.”

The complexities of biosimilar naming in the United States also continue to be a challenge, and Frame noted that the FDA’s policy of adding suffixes to the nonproprietary names of biosimilars—although not retroactively to the names of originator products approved before suffixes came into play—continue to cause confusion in the marketplace. When considering these suffixes, “What value for patients is actually being achieved?”

Yoon added that, in addition to resolving these US-specific challenges, Sandoz would also like to see greater regulatory harmonization between the US and other highly regulated territories.

According to Yoon, Sandoz supports using a global reference product for biosimilar development, provided the comparator is authorized by a Stringent Regulatory Authority, has a complete registration dossier inclusive of safety and efficacy studies in all indications, and has a public assessment report if it was approved outside of the United States.

Sandoz also stands in favor of waiving bridging studies for US and ex-US reference products in biosimilar development, so long as the foreign comparator has the same form and route of administration, the same active pharmaceutical ingredient, and the same excipients as the US product and meets the same criteria as the proposed global comparator.

The company also has policy priorities as it looks ahead to the next years of the BPCIA; through its work with the Biosimilars Forum, which represents biosimilar drug makers, Sandoz is advocating for incentives that will help push biosimilars forward. Those incentives include changes to Medicare Part B that would eliminate co-pays for biosimilars at the patient level, increases to physician reimbursement for biosimilars, and formation of a CMS star rating for institutions that make biosimilars available.

“Now that we have real-world evidence in the United States, especially with Zarxio, I think there’s much more openness to using [biosimilars], but if we could get that incentive in place and aligned across the system, then I think patients will benefit, as well the system overall,” said Frame.

Yoon, too, pointed to experience with Zarxio as an encouraging sign that biosimilars are poised to see increased success and to deliver on their promise to make headroom for improved patient care in the years ahead.

“When we talk to practices that participate in Oncology Care Model,” said Yoon, “they’ve achieved benefit by incorporating biosimilars into their practice…they’ve taken those savings that have been generated with biosimilars to provide additional patient care services. For example, more staff to provide additional urgent care appointments, which ultimately reflects directly on one of the quality metrics, which is reduced [emergency department] visits.”

Sandoz also plans to take the lessons learned from its years of experience with Zarxio into new launches, including that of Ziextenzo, which came to the market at an approximately 37% discount to the list price of the reference product—among the deepest discounts seen in the biosimilar space to date.

Frame noted that this is “the first time there’s a third biosimilar entering” for a given reference, “so we come to a very open and flexible and agile environment,” one in which the company will rely on the expertise of its commercial and medical teams to compete with other pegfilgrastim producers. Yoon added that the company’s demonstrated record of steady product supply will be a help in competing with other biosimilar developers in this space.

Of course, one product of Sandoz’s that has been approved but not yet launched is its etanercept biosimilar, Erelzi. The product has been the subject of a long, complex patent litigation, and the company faced a setback earlier this year when a court sided with Neulasta-maker Amgen over Sandoz.

Said Frame, “We are absolutely committed to success” with Erelzi. “We know what the potential savings are for patients in the United States when we launch, and that we’ve had good success across Europe with that product. So we’re certainly excited to bring it to the US market as soon as legally possible.”